Bonnie and Tom Strauss Movement Disorders Center

Clinical Trials

We invite our patients to participate in clinical trials, which evaluate the effectiveness of novel therapies and offer access to emerging treatment options.

Parkinson’s Disease

A Phase 3, Twelve-Week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety, and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects with Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER.

Sponsor: Pharma2B

Synopsis: This is a study for early stage, untreated Parkinson's disease patients with disease duration of less than three years. Patients in the study will be randomized to one of four different active treatment arms, and one treatment arm will include the Pharma 2B combination pill of low dose rasagiline and pramipexole. There is no placebo in this study. Patients will be asked to fill out study scales and questionnaires related to their Parkinson's disease.

Link: https://clinicaltrials.gov/show/NCT03329508

Study Contacts: Mindy Lopez, senior research manager, 212-241-9038, email: mindy.lopez1@mssm.edu

Joan Bratton, 212-241-0279, email: joan.bratton@mssm.edu

Winona Tse, MD, Principal Investigator, 212-241-6960, email: winona.tse@mssm.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson’s Disease-Related Constipation (KARMET) And Rollover Study: A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients with Parkinson’s Disease and Constipation over a 14-week Period.

Sponsor: Enterin

Synopsis: This study is looking at the effects of a novel medication to treat Parkinson's disease-related constipation. Patients will be randomized in a 3:1 ratio of active study drug to placebo. Patients will fill out weekly bowel movement diaries and other study scales and will be allowed to adjust their study drug dosing based on their symptoms. Rescue medication will be provided to ensure that the patients move their bowels on a regular basis. Patients who complete the main study will have the option to possibly rollover into an extended open label follow-up study.

Link: https://clinicaltrials.gov/NCT03781791

Study Contacts: Mindy Lopez, senior research manager, 212-241-9038, email: mindy.lopez1@mssm.edu

Joan Bratton, 212-241-0279, email: joan.bratton@mssm.edu

Winona Tse, MD, Principal Investigator, 212-241-6960, email: winona.tse@mssm.edu

A Multicenter, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects with Parkinson’s Disease Experiencing Motor Fluctuations (BouNDless).

Sponsor: Neuroderm

Synopsis: Patients with Parkinson's disease and bothersome motor fluctuations and wearing off may be eligible to participate in this study of the effects of continuously administered subcutaneous levodopa through a pump on their motor fluctuations. Patients will need to meet a minimum level of number of hours of wearing off per day in order to qualify. Patients will be enrolled in open label medication adjustment, then will enter a conversion period to subcutaneous levodopa, then will be randomized to receive either subcutaneous carbidopa/levodopa or its matching placebo and oral carbidopa/levodopa.

Link: https://clinicaltrials.gov/NCT04006210

Study Contacts: Mindy Lopez, senior research manager, 212-241-9038, email: mindy.lopez1@mssm.edu

Joan Bratton, 212-241-0279, email: joan.bratton@mssm.edu

Winona Tse, MD, Principal Investigator, 212-241-6960, email: winona.tse@mssm.edu

A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson’s Disease (THIS STUDY IS NOT YET READY FOR PATIENT RECRUITMENT, PENDING)

Sponsor: NIH, funded through NeuroNEXT

Synopsis: Patients with Parkinson's disease (PD) and sleep disturbance may qualify for this study. This study is looking at the effects of different types of light and different doses of light administration through a lightbox on the sleep patterns of PD patients. It is hypothesized that light therapy may improve sleep problems in PD patients. Patients will be taught to self-administer the light therapy using a lightbox at home. Patients must be willing to complete daily sleep logs and wear an Actiwatch.

Link: https://clinicaltrials.gov/NCT04006210

Study Contacts: Mindy Lopez, senior research manager, 212-241-9038, email: mindy.lopez1@mssm.edu

Joan Bratton, 212-241-0279, email: joan.bratton@mssm.edu

Winona Tse, MD, Principal Investigator, 212-241-6960, email: winona.tse@mssm.edu

Post Market Clinical Follow-Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System, 36-month Extended Follow-Up.

(This study is not recruiting new patients, so no link is provided. Patients enrolled in initial study will be asked to enroll in the extended follow-up)

Sponsor: Abbott

Synopsis: This is a follow-up extension study of the PROGRESS Abbott study, which we participated in at our center, looking at the effects of directional deep brain stimulation (DBS) on the therapeutic window of DBS in Parkinson’s disease patients who have undergone DBS implantation using the Abbott DBS system.

Study Contacts: Mindy Lopez, senior research manager, 212-241-9038, email: mindy.lopez1@mssm.edu

Joan Bratton, 212-241-0279, email: joan.bratton@mssm.edu

Winona Tse, MD, Principal Investigator, 212 241 6960, email: winona.tse@mssm.edu

A Randomized and Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release Carbidopa-Levodopa in Parkinson’s Disease Patients with Motor Fluctuations

Sponsor: Impax Pharmaceuticals

Synopsis: This is a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. Patients will have their regular carbidopa/levodopa dose adjusted and optimized, then will be converted to IPX203, and then be randomized to treatment with regular carbidopa/levodopa or IPX203 for a 13-week double-blind treatment period.

Link: https://clinicaltrials.gov/ct2/show/NCT03670953

Contact: Syeda Tania, clinical research coordinator: 212-523-8364, email: syeda.tania@mountsinai.org

Deep Brain Stimulation Studies:

Patients with movement disorders who are candidates for deep brain stimulation are invited to participate in various research studies assessing the biochemistry and neurophysiology of the brain, imaging protocols, motor and non-motor symptoms, and long-term follow-up assessments (including longitudinal patient registries). Participation in this research is offered to patients at the time they are undergoing pre-operative evaluations.

Contact: Syeda Tania, clinical research coordinator: 212-523-8364, email: syeda.tania@mountsinai.org

Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-Stage Parkinson's Disease Carrying a GBA Mutation or Other Prespecified Variant.  BRANY # 17-02-7405

Sponsor: Sanofi Genzyme

Approved by IRB (BRANY) on 12/11/2018

Synopsis: This is a randomized, multicenter trial for patients with early-stage Parkinson’s disease without dementia, who carry a mutation in the GBA1 gene. Subjects are randomized to placebo or an active drug that is being investigated as a new therapy for GBA-associated Parkinson’s disease. Subjects will undergo regular neurological examinations and cognitive testing.

Status: Closed to enrollment

Study contact: Ricardo Renvill, 212-844-6055, email: ricardo.renvill@mssm.edu

Site Principal Investigator: Matthew Swan, MD, email: matthew.swan@mountsinai.org

A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety, and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients.

Approved by IRB (BRANY) on 4/15/2020

Synopsis: This is a randomized, multicenter trial for patients with Parkinson’s disease who are taking levodopa, and who experience wearing off from their medication. This study is designed to assess the effectiveness of a continuous subcutaneous infusion of carbidopa/levodopa compared to carbidopa/levodopa tablets. Subjects will be optimized on oral carbidopa/levodopa tablets, and then will be randomly assigned to 2 study arms, either carbidopa/levodopa infusion plus placebo tablets, or placebo infusion plus carbidopa/levodopa tablets. Subjects will return regularly for standardized exams, and must also complete regular symptom diaries between study visits.

Status: Not yet recruiting

Study contact: Ricardo Renvill, 212-844-6055, email: ricardo.renvill@mssm.edu

Site Principal Investigator: Matthew Swan, MD, email: matthew.swan@mountsinai.org

A Validation Study to Assess the Validity, Measurement Responsiveness, and Reliability of the Parkinson's Disease Functional Impacts Digital Instrument (PD-FIDI) in Patients with Parkinson's Disease with or without GBA Mutations.

Sponsor: Sanofi Genzyme

Approved by IRB (BRANY) on 6/24/2020

Synopsis: This is a study to explore the feasibility of a wearable monitor to assess Parkinson’s disease motor symptoms. The study will enroll subjects with early- or mid-stage Parkinson’s disease on stable doses of medication. All subjects will be asked to use a wrist-worn monitor for 24 hours once a week.

Status: Not yet recruiting

Study contact: Ricardo Renvill, 212-844-6055, email: ricardo.renvill@mssm.edu

Site Principal Investigator: Matthew Swan, MD, email: matthew.swan@mountsinai.org

A Phase 1/2a Randomized, Double-Blind, Sham Procedure-Controlled, Ascending Dose Study to Evaluate the Safety of PR001A in Patients with Parkinson’s Disease with at Least One GBA1 Mutation (PROPEL).

-The initial submission is approved, contract is finalized.

Sponsor: Prevail Therapeutics

Approved by IRB on 2/21/2020

Synopsis: This is a study to assess the safety and tolerability of a novel gene therapy for patients with Parkinson’s disease who carry a mutation in the GBA1 gene. The study will enroll subjects with GBA-associated Parkinson’s disease who do not have severe dementia, and all subjects will be randomly assigned to receive an active gene therapy or placebo. Gene therapy is delivered by injection into the cerebrospinal fluid. Subjects will return to clinic for regular physical exams and questionnaires.

Status: Not yet recruiting

Study contact: Ricardo Renvill, 212-844-6055, email: ricardo.renvill@mssm.edu

Site Principal Investigator: Susan Bressman, MD, email: susan.bressman@mountsinai.org

Tics/Tourette Syndrome Studies:

We are looking for volunteers for an electroencephalography (EEG) study located at Mount Sinai West.

The purpose of this research study is to create a measure of brain activity in the insula. The insula is the part of the brain that is responsible for the way we feel sensations inside our body. An example of an internal body sensation is our heartbeat.

Contact: Syeda Tania, clinical research coordinator: 212-523-8364, email: syeda.tania@mountsinai.org